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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
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 belowSelect...
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:Select...
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.
Select...
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
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 moreTrial 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
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,013,077 Total Patients Enrolled
45 Trials studying Heart Failure
10,848 Patients Enrolled for Heart Failure
Julio Chirinos, MD, PhDUNKNOWN
Raymond Townsend, MDUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to amlodipine besylate or metoprolol succinate in the past.I have been diagnosed with heart failure.I have a serious lung condition.Your heart has high pressure, as determined by specific measurements.I am between 18 and 90 years old.I have a lung artery disease.I have been diagnosed with high blood pressure.My kidney function is severely reduced.I have active heart artery disease.My blood pressure medication has not changed in the last 30 days.You are not able or willing to do physical activity.Your heart rate at rest is either too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute).Specific results from a heart ultrasound testMy blood pressure meets the required levels.Your heart's pumping function is too strong, with an ejection fraction over 50%.I cannot stop taking my calcium channel blocker or beta-blocker medication.
Research Study Groups:
This trial has the following groups:- Group 1: Metoprolol succinate
- Group 2: Amlodipine besylate
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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