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Vasodilator

Blood Flow Improvement Drugs + Supplements for Heart Failure (MPMA Trial)

Phase 2

Recruiting

Led By Payman Zamani, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Left ventricular ejection fraction >= 50%

NYHA Class II-III symptoms

Must not have

Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1<50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea, desaturation to <90% on the baseline maximal effort cardiopulmonary exercise test

Age <18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6

Summary

This trial will test whether drugs that improve blood flow, with or without supplements that may improve mitochondrial function, can improve exercise endurance and skeletal muscle function in people with HFpEF.

Who is the study for?

This trial is for adults with Heart Failure with Preserved Ejection Fraction (HFpEF), who have been on stable heart medication for at least a month. They should have certain signs of heart stress, like specific ratios in their echocardiogram or history of acute heart failure. Excluded are those under 18, pregnant women, people with severe other diseases or conditions that could interfere with the study, and those taking conflicting medications.

What is being tested?

The study tests if Potassium Nitrate alone or combined with Propionyl-L-Carnitine and Nicotinamide Riboside can improve exercise endurance and muscle function in HFpEF patients. It compares these treatments to Potassium Chloride to see which is better at increasing blood flow and enhancing mitochondrial function.

What are the potential side effects?

Possible side effects may include changes in blood pressure, dizziness upon standing due to orthostatic hypotension, potential impact on liver enzymes (ALT/AST levels), alterations in kidney function as measured by eGFR rates, and increased methemoglobin levels which affect oxygen delivery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart pumps blood effectively.

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I have moderate heart condition symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe lung disease or need extra oxygen.

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I am under 18 years old.

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I have significant heart valve issues.

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My heart's right side is not pumping well.

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I am taking medication for heart or erection problems that cannot be stopped.

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I have high blood pressure in the lungs' arteries.

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My heart often beats faster than 100 beats per minute.

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I have a diagnosed heart muscle condition.

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My liver is not working well (high enzyme levels or low albumin).

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Submaximal Exercise Endurance

Secondary study objectives

Kansas City Cardiomyopathy Questionnaire Overall Summary Score

Peak VO2

Skeletal muscle structure

+4 more

Other study objectives

Change in Skeletal Muscle Oxidative Capacity

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Potassium NitrateActive Control1 Intervention

Potassium Nitrate (KNO3) 6 mmol three times daily

Group II: Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide RibosideActive Control1 Intervention

Potassium Nitrate (KNO3) 6 mmol three times daily + Propionyl-L-Carnitine (PLC) 1000 mg twice daily + Nicotinamide Riboside (NR) 300 mg three times daily

Group III: Potassium ChloridePlacebo Group1 Intervention

Potassium Chloride (KCl) 6 mmol three times daily

0 / 12Eligibility criteria met