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Metabolic Mapping and Cardiac Resynchronization
NA trial testing Cardiac resynchronization therapy pacemaker (CRT-P) in Heart Failure in 82 participants. Completed in 19 December 2023.
| Lead sponsor | Yong-Mei Cha |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 82 |
| Start date | 20 August 2018 |
| Primary completion | 19 December 2023 |
| Estimated completion | 19 December 2023 |
| Sites | 1 location across United States |
Yong-Mei Cha
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | -11.6 | ± 12.8 |
| CRT-OFF | -4.1 | ± 12.2 |
This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | 2 | |
| CRT-OFF | 2 |
The total number of subjects hospitalized for heart failure during the study.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | 0 | |
| CRT-OFF | 0 |
The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months.
| Group | Value | 95% CI |
|---|---|---|
| CRT-On First, Then CRT-Off | 0.1 | ± 0.6 |
| CRT-Off First, Then CRT-On | -0.3 | ± 0.6 |
In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | 1 | |
| CRT-OFF | 0 |
LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | 5.3 | ± 8.2 |
| CRT-OFF | 2.2 | ± 7.0 |
The total number of subjects to die for any reason during the study.
| Group | Value | 95% CI |
|---|---|---|
| CRT-ON | 0 | |
| CRT-OFF | 3 |
Time frame: Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CRT-ON | CRT-OFF |
|---|---|---|---|
| Deep Vein Thrombosis | General disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Lead dislodgment | General disorders | — | — |
| Syncope | General disorders | — | — |
| Sustained Ventricular Tachycardia | Cardiac disorders | — | — |
| Electrical Stimulation | General disorders | — | — |
| Diaphragmatic Stimulation | General disorders | — | — |
| Pneumothorax | General disorders | — | — |
| Sepsis | General disorders | — | — |
| Ischemic Stroke | General disorders | — | — |
| Reaction | System | CRT-ON | CRT-OFF |
|---|---|---|---|
| Anemia | General disorders | — | — |
| Hyperglycemia | General disorders | — | — |
| Chest pain | General disorders | — | — |
| Dizziness | General disorders | — | — |
| COVID-19 | General disorders | — | — |
| Dyspenea | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Cough | General disorders | — | — |
| Tenderness at implant site | General disorders | — | — |
| Shortness of breath | General disorders | — | — |
Most-reported serious reactions: Deep Vein Thrombosis, Pericardial effusion, Lead dislodgment, Syncope, Sustained Ventricular Tachycardia, Electrical Stimulation, Diaphragmatic Stimulation, Pneumothorax.
Data from ClinicalTrials.gov NCT03420833 adverse events section.
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing