Apresoline

Hypertension, Congestive Heart Failure, Hypertension + 1 more

Treatment

2 FDA approvals

20 Active Studies for Apresoline

What is Apresoline

Hydralazine

The Generic name of this drug

Treatment Summary

Hydralazine is a medication used to treat high blood pressure and heart failure. It was originally developed in the 1950s as a malaria treatment, but was later discovered to reduce hypertension. It is no longer used as a first line treatment for hypertension, as newer medications are available. Hydralazine hydrochloride was approved by the FDA in 1953.

Apresoline hydrochloride

is the brand name

image of different drug pills on a surface

Apresoline Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Apresoline hydrochloride

Hydralazine

1953

300

Approved as Treatment by the FDA

Hydralazine, also called Apresoline hydrochloride, is approved by the FDA for 2 uses which include Hypertensive disease and Hypertension, Essential Hypertension .

Hypertensive disease

Helps manage Hypertension, Essential Hypertension

Hypertension, Essential Hypertension

Helps manage Hypertension, Essential Hypertension

Effectiveness

How Apresoline Affects Patients

Hydralazine helps to relax the small muscles of the arteries, which reduces blood pressure. The effects of the drug usually last 2-6 hours. It is generally safe and can be taken in doses of up to 300mg. However, people should be aware of the risk of developing systemic lupus erythematosus syndrome when taking this drug.

How Apresoline works in the body

Hydralazine works to lower blood pressure by blocking calcium from entering cells in vascular smooth muscle. This reduces the resistance in the blood vessels and increases the heart rate, stroke volume, and cardiac output. Hydralazine also prevents a protein called protocollagen prolyl hydroxylase from binding to free iron. This stops the breakdown of HIF-1α, which encourages the growth of new blood vessels and helps them regenerate.

When to interrupt dosage

The proposed measure of Apresoline is contingent upon the specified condition, including Hypertensive crisis, Hypertensive disease and Pregnancy. The quantity of dosage is dependent upon the technique of delivery (e.g. Tablet, coated - Oral or Tablet) detailed in the table beneath.

Condition

Dosage

Administration

Hypertensive disease

, 20.0 mg/mL, 10.0 mg, 25.0 mg, 50.0 mg, 100.0 mg, 37.5 mg

, Injection, solution, Injection, solution - Intramuscular; Intravenous, Intramuscular; Intravenous, Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, solution - Intramuscular; Intravascular, Intramuscular; Intravascular, Solution, Intravenous, Solution - Intravenous, Capsule - Oral, Capsule, Tablet, coated - Oral, Tablet, coated, Injection - Intramuscular; Intravascular, Injection, Injection - Intramuscular; Intravenous

Hypertension

, 20.0 mg/mL, 10.0 mg, 25.0 mg, 50.0 mg, 100.0 mg, 37.5 mg

, Injection, solution, Injection, solution - Intramuscular; Intravenous, Intramuscular; Intravenous, Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, solution - Intramuscular; Intravascular, Intramuscular; Intravascular, Solution, Intravenous, Solution - Intravenous, Capsule - Oral, Capsule, Tablet, coated - Oral, Tablet, coated, Injection - Intramuscular; Intravascular, Injection, Injection - Intramuscular; Intravenous

Congestive Heart Failure

, 20.0 mg/mL, 10.0 mg, 25.0 mg, 50.0 mg, 100.0 mg, 37.5 mg

, Injection, solution, Injection, solution - Intramuscular; Intravenous, Intramuscular; Intravenous, Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, solution - Intramuscular; Intravascular, Intramuscular; Intravascular, Solution, Intravenous, Solution - Intravenous, Capsule - Oral, Capsule, Tablet, coated - Oral, Tablet, coated, Injection - Intramuscular; Intravascular, Injection, Injection - Intramuscular; Intravenous

Hypertension

, 20.0 mg/mL, 10.0 mg, 25.0 mg, 50.0 mg, 100.0 mg, 37.5 mg

, Injection, solution, Injection, solution - Intramuscular; Intravenous, Intramuscular; Intravenous, Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated, Injection, solution - Intramuscular; Intravascular, Intramuscular; Intravascular, Solution, Intravenous, Solution - Intravenous, Capsule - Oral, Capsule, Tablet, coated - Oral, Tablet, coated, Injection - Intramuscular; Intravascular, Injection, Injection - Intramuscular; Intravenous

Warnings

Apresoline Contraindications

Condition

Risk Level

Notes

Coronary Disease

Do Not Combine

Rheumatic Heart Disease

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Hydralazine may interact with Pulse Frequency

There are 20 known major drug interactions with Apresoline.

Common Apresoline Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be decreased when combined with Hydralazine.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be decreased when combined with Hydralazine.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Hydralazine.

Alpelisib

Major

The metabolism of Alpelisib can be decreased when combined with Hydralazine.

Amifostine

Major

Hydralazine may increase the hypotensive activities of Amifostine.

Apresoline Toxicity & Overdose Risk

The lowest toxic dose of the drug in rats is 173-187mg/kg, and the highest known dose an adult human has survived is 10g. Symptoms of an overdose may include low blood pressure, rapid heart rate, headache, redness of the skin, lack of oxygen to the heart, heart attack, abnormal heart rhythm, and shock. Treatment for overdose includes emptying the stomach contents and administering activated charcoal, though this can lead to further arrhythmias and shock. Patients should receive supportive and symptomatic care.

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Apresoline Novel Uses: Which Conditions Have a Clinical Trial Featuring Apresoline?

352 active clinical trials are presently exploring the potential of Apresoline to mitigate Hypertensive disease, Congestive Heart Failure and Hypertensive crisis.

Condition

Clinical Trials

Trial Phases

Hypertension

0 Actively Recruiting

Congestive Heart Failure

176 Actively Recruiting

Not Applicable, Phase 1, Early Phase 1, Phase 4, Phase 2, Phase 3

Hypertension

0 Actively Recruiting

Hypertensive disease

3 Actively Recruiting

Not Applicable, Phase 3

Apresoline Reviews: What are patients saying about Apresoline?

4.7

Patient Review

1/19/2009

Apresoline for High Blood Pressure

2

Patient Review

8/18/2009

Apresoline for High Blood Pressure

1.7

Patient Review

10/6/2019

Apresoline for High Blood Pressure

Though it did lower my blood pressure, I felt like all of my energy was gone. It's effects were very sudden and severe. I only messed with it for a week because of how bad it made me feel, and I almost lost my job because of it. On top of that, I fractured my elbow while taking it.

1

Patient Review

9/30/2009

Apresoline for High Blood Pressure

My sister had a terrible reaction to this medication. It caused lupus and she ended up in the hospital for two weeks as a result. I would not recommend this drug to anyone after seeing what it did to her.

1

Patient Review

3/10/2010

Apresoline for High Blood Pressure

The pills are large and bitter, which makes them hard to take.

1

Patient Review

11/6/2008

Apresoline for High Blood Pressure

1

Patient Review

8/5/2018

Apresoline for High Blood Pressure

I had an extremely negative reaction to this drug. I felt intense chest pain, dizziness, and a headache that lasted for over 24 hours after taking it. I would never recommend this medication to anyone.

1

Patient Review

9/13/2016

Apresoline for High Blood Pressure

The medicine caused some serious side effects for me, including headaches, heart palpitations, loss of appetite and nausea.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about apresoline

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the drug Apresoline used for?

"Hydralazine is used to lower blood pressure, either on its own or with other medications. This reduces the risk of strokes, heart attacks and kidney problems, as hydralazine causes the blood vessels to dilate, improving blood flow around the body."

Answered by AI

What type of drug is Apresoline?

"Apresoline is a prescription medicine used to treat chronic high blood pressure, Hypertensive Crisis, and Congestive heart failure. Apresoline may be used alone or with other medications. Apresoline belongs to a class of drugs called Vasodilators."

Answered by AI

What are side effects for hydralazine?

"You may experience flushing, headache, upset stomach, vomiting, loss of appetite, diarrhea, constipation and eye tearing."

Answered by AI

Is Apresoline a water pill?

"Does hydralazine make you urinate more?

No, hydralazine does not make you urinate more because it is not a water pill. It works by relaxing your blood vessels to lower your blood pressure."

Answered by AI

Clinical Trials for Apresoline

Image of Columbia University in New York, United States.

MediBeacon Transdermal GFR System for Heart Failure

18+
All Sexes
New York, NY

The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure. The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement. Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.

Waitlist Available
Has No Placebo

Columbia University

Richard B Dorshow, PhD

MediBeacon

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Clinical Decision Support Tool for Heart Failure

18 - 85
All Sexes
Boston, MA

This study is an investigator-initiated, cluster-randomized implementation trial evaluating a large language model (LLM)-based clinical decision support (CDS) tool designed to improve guideline-directed medical therapy (GDMT) for adult patients with heart failure seen in outpatient cardiology clinics at Mass General Brigham. For eligible heart failure encounters, the CDS tool reviews existing electronic health record (EHR) data, including diagnoses, medications, vital signs, laboratory results, and recent notes, and generates brief, clinician-facing messages suggesting opportunities to initiate or optimize GDMT and highlighting relevant safety considerations. Messages are delivered to cardiology providers via Epic InBasket and/or institutional email prior to scheduled visits. The tool is advisory only and cannot place orders or change medications automatically; all treatment decisions remain at the discretion of the treating clinician and patient. Cardiology providers are assigned at the provider/clinic level to early implementation of the CDS tool versus usual care (no messages) during the initial phase. The primary outcome is GDMT optimization within 30 days of an index visit. Secondary outcomes include feasibility of CDS generation and delivery and a 30-day safety composite (e.g., heart failure hospitalization, acute kidney injury, hyperkalemia, hypotension or bradyarrhythmia plausibly related to GDMT).

Waitlist Available
Has No Placebo

Mass General Brigham

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FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

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Deprescribing Beta-Blockers for Diastolic Heart Failure

18+
All Sexes
Pleasanton, CA

The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.

Phase 4
Waitlist Available

Kaiser Permanente Northern California (KPNC)

Parag Goyal, MD, MSc

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Dapagliflozin for Heart Failure

18 - 85
All Sexes
New Haven, CT

The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.

Phase 2
Waitlist Available

Yale New Haven Hospital-St. Raphael Campus (+1 Sites)

Abinet Aklilu, MD

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Finerenone for Heart Failure

18+
All Sexes
Cambridge, Canada

The goal of this clinical trial is to learn if the drug finerenone (Karendia) can improve heart function in participants who are at risk for heart and kidney disease. The main question it aims to answer is whether adding finerenone to standard-of-care heart failure medical therapies will beneficially alter the heart structure and function of people who have risk factors for heart and kidney complications and whose left side of the heart is enlarged. The researchers will compare finerenone to a placebo (a look-alike substance that contains no drug) to see if finerenone improves heart structure and function. Participants will: * take a finerenone or a placebo tablet once a day for 12 months * have a cardiac magnetic resonance imaging (cMRI; a safe, non-invasive scan to measure heart mass, stiffness and function) test at the beginning of the study and 12 months later * visit the clinic after one, three, six and twelve months to assess overall health and/or perform blood or urine tests

Phase 3
Waitlist Available

Cambride Cardiac Care Centre (+2 Sites)

Subodh Verma, MD, PhD

Bayer

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Furosemide for Heart Failure

18+
All Sexes
Lakeland, FL

The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care. The main questions it aims to answer are: 1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis? 2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions? 3. Does targeting a higher urine sodium goal reduce hospital length of stay? Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice. Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.

Phase 4
Waitlist Available

Lakeland Regional Hospital

Anas Bizanti, MD

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Supportive Management for Heart Failure and Methamphetamine Addiction

18+
All Sexes
Los Angeles, CA

Heart failure (HF) affects over 6 million people in the US and is a major cause of both hospital admissions and death. HF has many causes and contributing factors. One of the most aggressive forms of HF is associated with methamphetamine abuse, which has become its own epidemic in the US over the past twenty years. People who use methamphetamine tend to develop HF at a much younger age, with more severe disease and more serious consequences. A recent analysis using nationwide data, methamphetamine use doubled the risk of death or hospitalizations compared to non-users in patients with HF. Thus, methamphetamine users with HF represent a very high-risk group of patients from a healthcare perspective. HF may be reversible in some patients who use methamphetamine if patients can achieve 1) abstain from further methamphetamine use and 2) consistently take all the medications that can improve HF. These two goals are very difficult to achieve in practice, as the care of both methamphetamine addiction and HF requires specialized medical expertise and intensive regular follow up of patients. In general, achievement of one goal is not possible without the other. Patients who use methamphetamine have poor adherence to medical follow-up and therapies, and abstinence from methamphetamine is difficult to maintain. This is further complicated because the current model of HF care does not incorporate treatment for methamphetamine use. The current study proposes to launch a multidisciplinary clinic that treats both HF and methamphetamine use disorder at the same time. The HF care will be led by a cardiologist while the methamphetamine use treatment will be led by a psychiatric clinical pharmacist trained in addiction medicine. State-of-the-art HF care will include optimization of four pillar HF medications. Methamphetamine use treatment will include counseling and incentivized abstinence known as contingency management (CM). The investigators will manage the patients in the clinic for 6 months total. The investigators are interested in demonstrating that this integrated clinic model will result in improved delivery of care for these patients by reporting the rates of successful abstinence from methamphetamine, improved optimization of the four HF medications, and enhanced patient reported quality of life over the 6 months of follow up. The investigators will also collect data on the costs associated with providing this level of care and estimate a range of potential cost-savings.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center (+1 Sites)

Tien Ng, PharmD

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