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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

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I have been diagnosed with heart failure.

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I am between 18 and 90 years old.

Exclusion Criteria

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

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I have a serious lung condition.

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I have a lung artery disease.

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My kidney function is severely reduced.

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I have active heart artery disease.

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My blood pressure meets the required levels.

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I cannot stop taking my calcium channel blocker or beta-blocker medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at the end of each of the two 4-week intervention phases

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

0 / 8Eligibility criteria met