← Back to Search

Calcium Channel Blocker

Calcium Channel Blocker + Beta Blocker for Heart Failure (BLOCK HFpEF Trial)

Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of heart failure
Adults age 18-90 years
Must not have
Clinically significant lung disease
Primary pulmonary arteriopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at the end of each of the two 4-week intervention phases
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is investigating whether or not calcium channel blockers and beta blockers, two common types of blood pressure medication, are effective in treating heart failure with preserved ejection fraction.

Who is the study for?
This trial is for adults aged 18-90 with stable high blood pressure treatment, diagnosed heart failure, specific elevated heart pressures, and a history of hypertension. They must have a normal left ventricular ejection fraction (>50%). Excluded are those with certain blood pressure levels, severe lung disease or coronary artery disease, allergies to the drugs tested, kidney issues (eGFR <30), or conditions affecting study participation.
What is being tested?
The trial investigates how two common blood pressure medications—Amlodipine Besylate (a calcium channel blocker) and Metoprolol Succinate (a beta-blocker)—impact heart function in patients with HFpEF. It aims to understand which medication better targets the physiological abnormalities associated with this type of heart failure.
What are the potential side effects?
Potential side effects include dizziness due to low blood pressure from Amlodipine Besylate and fatigue or shortness of breath from Metoprolol Succinate. Both drugs may cause swelling in the limbs and irregular heartbeat; individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with heart failure.
Select...
I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious lung condition.
Select...
I have a lung artery disease.
Select...
My kidney function is severely reduced.
Select...
I have active heart artery disease.
Select...
My blood pressure meets the required levels.
Select...
I cannot stop taking my calcium channel blocker or beta-blocker medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at the end of each of the two 4-week intervention phases
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the end of each of the two 4-week intervention phases for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in home systolic blood pressure
Secondary study objectives
Change in arterial wave reflections
Change in home diastolic blood pressure
Change in large artery stiffness
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Metoprolol succinateActive Control1 Intervention
Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
Group II: Amlodipine besylateActive Control1 Intervention
Initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,998 Total Patients Enrolled
47 Trials studying Heart Failure
10,972 Patients Enrolled for Heart Failure
Julio Chirinos, MD, PhDUNKNOWN
Raymond Townsend, MDUNKNOWN

Media Library

Amlodipine Besylate (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04434664 — Phase 4
Heart Failure Research Study Groups: Metoprolol succinate, Amlodipine besylate
Heart Failure Clinical Trial 2023: Amlodipine Besylate Highlights & Side Effects. Trial Name: NCT04434664 — Phase 4
Amlodipine Besylate (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04434664 — Phase 4
~7 spots leftby Aug 2025