An exploratory study for therapeutic effects of geranylgeranylacetone on heart failure

JRCT ID: jRCTs031220395

Registered date:19/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart failure
• Date of first enrollment: 19/10/2022
• Target sample size: 160
• Study type: Interventional

Intervention(s)

Random Allocation of teprenone (GGA) to the patients recieved standard therapeutic
strategies for heart failure.

Outcome(s)

Primary Outcome

Change in NT-ProBNP value 24 weeks after the start of GGA administration.
Changes in CK-MB and troponin values as indicators of cell injury.

Secondary Outcome

1.change in BNP value at the time of 1,2,4,12,24 weeks after the start of GGA administration.
2.following items at the time of 1,2,4,12,24 weeks after the start of GGA administration.
-subjective symptoms (NYHA classification)
-KCCQ (Kansas City Cardiomyopathy Questionnaire)
-left ventricular ejection fraction, diastolic function (E/A, DecT, E/e), pulmonary artery pressure evaluated by echocardiogram
-CTR, tracheal bifurcation angle evaluated by chest X-ray
-Physical function: Grip power, 6-minute walking distance, walking speed, comprehensive lower limb function
-5-year survival prediction using cardiac sympathetic nerve function (MIBG))
-heart failure readmission, all cause death, cardiac death

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. inpatient
2. patients recerving standard treatment for heart failure in cardiology
3. patients aged 18 years or older at the time of concent(regardless of gender)
4. patients who have received sufficient explanation of this study and have voluntarily
consented by the mselves or their substitute.

Exclude criteria

1.patients taking GGA (including over-the-counter drugs contains GGA,such as Selbelle etc) within 1 month before obtaining consent
2.patients with severe valvular disease, acute myocardial infarction, unstable angina
3.patients receiving WAON therapy(soothing warm therapy) within 1 month before obtaining consent
4.patients who is not able to take capsels
5.patients with serious liver disease distinct from congestion
6.patients receiving dialysis
7.pregnant or potentially pregnant women
8.lactating women
9.patients with allergies to GGA
10.patients without the agreement to participate in this study by them or their substitute
11.patients who evaluated by the principal investigator to be inappropriate as a research subject

Related Information

• Primary Sponsor: Akasaka Takeshi