Which blood pressure pill works best for this type of heart failure?
NCT ID NCT04434664
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two common blood pressure medications—amlodipine and metoprolol—in 50 adults with heart failure with preserved ejection fraction (HFpEF) and hypertension. Participants took each drug for a period, and researchers measured their home blood pressure readings. The goal was to see which drug better controlled blood pressure in this specific heart condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amlodipine and metoprolol
- What this could lead to
- If successful, this could help doctors choose better blood pressure medications for people with a common type of heart failure.
- What could go wrong
- This is a small, completed study (50 participants) that may not apply to all patients. It compared two existing drugs, so no new treatment was discovered.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
50 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults age 18-90 years 2. Diagnosis of hypertension defined by at least two of the following: A) ICD-9 (401.0-404.91) or ICD-10 (I10-I13) codes signifying hypertension; B) Treatment with antihypertensive medication other than a loop diuretic for at least two months; C) History of previous blood pressure readings ≥130/80 mmHg at two separate office visits 3. Stable antihypertensive therapy; defined as no changes in antihypertensive medications in the preceding 30 days 4. A diagnosis of heart failure 5. LV ejection fraction \>50% 6. Elevated filling pressures defined by at least one of the following criteria: A) Mitral E/e' ratio (lateral or septal) \>8 with low e' velocity (septal e' \<7 cm/s or lateral e' \<10 cm/s) and at least one of the following: a. Enlarged left atrium (LA volume index \>34 ml/m2); b. Chronic loop diuretic use for management of symptoms; c. Elevated natriuretic peptides (BNP levels \>100 ng/L or NT-proBNP levels \>300 ng/L); B) Mitral E/e' ratio (lateral or septal) \>14; C) Previously elevated invasively determined filling pressures based on one of the following criteria: a. Resting LVEDP \>16 mmHg; b. Mean PCWP \>12 mmHg; c. PCWP or LVEDP ≥25 mmHg with exercise; D) Previous acutely decompensated heart failure requiring IV diuretics; Exclusion Criteria: 1. Systolic BP meeting any of the following criteria: A) Current office systolic BP \<100 mmHg; B) Current office systolic BP 100-119 mmHg if not receiving treatment with an antihypertensive agent or if holding antihypertensive medication prior to randomization would be clinically contraindicated, as per the investigator's clinical judgement; C) Current office systolic BP ≥180 mmHg if not receiving treatment with a CCB or β-blocker, or ≥160 mmHg if already receiving a CCB and/or β-blocker prior to the pre-randomization wash-out period; D) Orthostatic hypotension defined as \>20 mmHg decline in office systolic BP 3-5 minutes following the transition from sitting to standing position 2. Resting heart rate \<50 or \>100 bpm 3. Contraindication to withholding CCB or β-blocker therapy (e.g. use of non-dihydropyridine CCB \[diltiazem or verapamil\] or β-blocker for rate control for atrial fibrillation) as per the investigator's clinical judgement 4. Children, fetuses, neonates, prisoners, and pregnant women (women of childbearing age will undergo a pregnancy test during the screening visit) are not included in this research study. 5. Inability/unwillingness to exercise 6. Any the following echocardiographic findings: A) LV ejection fraction \<45% on any prior echocardiogram, unless it was in the setting of uncontrolled atrial fibrillation; B) Hypertrophic, infiltrative, or inflammatory cardiomyopathy; C) Clinically significant pericardial disease, as per investigator judgment; D) Moderate or greater left-sided valvular disease, any degree of mitral stenosis, or prosthetic mitral valve; E) Severe right-sided valvular disease; F) Severe right ventricular dysfunction 7. Active coronary artery disease, defined as any of the following: A) Acute coronary syndrome or coronary intervention in the past 2 months; B) Ischemia on stress testing without either subsequent revascularization or a subsequent angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgement 8. Clinically significant lung disease, defined as any of the following: A) Chronic Obstructive Pulmonary Disease meeting GOLD criteria stage III or greater; B) Treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease; C) The use of daytime supplemental oxygen 9. Primary pulmonary arteriopathy 10. eGFR \<30 mL/min/1.73m2 11. Any medical condition that, under the investigator's discretion, will interfere with safe completion of the study or validity of the endpoint assessments 12. Known history of an allergy or clinically significant sensitivity (as determined by the investigator) to either amlodipine besylate or metoprolol succinate
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Heart failure with preserved ejection fraction are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can pressing six points on the body help older adults sleep?
- Can AI-Tailored heat warnings shield chronic disease patients from dangerous temperatures?
- Could a quieter, automated blood pressure check help more people control hypertension?
- Can a phone call boost confidence in managing high blood pressure?
- Smart pillbox aims to keep patients on track
- Wristband vs. cuff: can a cuffless device match 24-Hour blood pressure monitoring?