Trial · NCT06597682
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators | 4 weeks | Assessing the difference in changes in cardiac magnetic resonance (CMR) indicators \[left ventricular ejection fraction, late gadolinium enhancement (LGE), and T1 and T2 mapping values (in milliseconds)\] from baseline between the experimental and control groups. |
| Primary | Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores | 8 weeks | Assessing the difference in changes in the Leicester Cough Questionnaire (LCQ) scale scores from baseline. The total score range of the LCQ is from 3 to 21 points, with higher scores indicating a lesser impact of cough on the patient's life. |
| Primary | Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores | 4 weeks | Assessing the difference in changes in the Fatigue Severity Scale (FSS) scale scores from baseline. The total score range of the FSS is from 9 to 63 points, with higher scores indicating a greater severity of fatigue. |
| Secondary | Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators | 4 weeks | Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline. |
| Secondary | Inflammatory Cardiac Involvement symptom cluster: VO2max | At baseline, 4 weeks | Assessing the changes in VO2max in cardiopulmonary exercise testing. |
| Secondary | Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores | At baseline, 4, 8, 12, and 24 weeks | Assessing the changes in the KCCQ scores between the experimental and control groups. The total score range of the KCCQ is from 0 to 100, with lower scores indicating poorer quality of life for heart failure patients. |
| Secondary | Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels | At baseline, 4, 8, 12 and 24 weeks | Measures the change in cardiac troponin T (cTNT) levels |
| Secondary | Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE) | From baseline to 52 weeks | From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups. |
| Secondary | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the EQ-5D-5L questionnaire scores between the experimental and control groups. The EQ-5D-5L is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) provides a descriptive profile that can be used to generate a health state profile. Each health state can be assigned a summary index score. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) scores | At baseline 4, 8, 12, and 24 weeks | Assessing the changes in the PSQI scores between the experimental and control groups. The total score range of the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality. |
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the GAD-7 scores between the experimental and control groups. The total score range of the GAD-7 is from 0 to 21, with higher scores indicating more severe anxiety. |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores | At baseline, 4, 8, 12 and 24 weeks | Assessing the changes in the PHQ-9 cores between the experimental and control groups. The total score range of the PHQ-9 is from 0 to 27, with higher scores indicating more severe depression. |
| Secondary | Cough symptom cluster: Visual Analogue Scale (VAS) | At baseline 4, 8 and 12 weeks | Assessing the change in the severity of cough as measured by the VAS between the experimental and control groups . The total score range of the VAS is from 0 to 100, with higher scores indicating more severe coughing in the patient. |
| Secondary | Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels | At baseline and 8 weeks | Assessing the changes in pulmonary function and FeNO levels between the experimental and control groups. |
| Secondary | Fatigue symptom cluster: Visual Analogue Scale (VAS) | At baseline, 4, 8, and 12 weeks | The total score range of the VAS is from 0 to 100, with higher scores indicating more severe fatigue in the patient. |
| Secondary | Change in proBNP Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in N-terminal pro-brain natriuretic peptide (proBNP) levels, which are associated with heart failure. |
| Secondary | Change in Angiotensin II Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in angiotensin II levels |
| Secondary | Change in Ferritin Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in ferritin levels |
| Secondary | Change in IL-6 Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in interleukin-6 (IL-6) levels |
| Secondary | Change in hsCRP Levels | Baseline, 4, 8, 12, 24 weeks | Measures the change in high-sensitivity C-reactive protein (hsCRP) levels |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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