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Heart Failure Research (I)

 

Heart failure research has been particularly biased against women, minorities and elderly patients over the years. This is disturbing because:

  • 80% of hospitalized HF patients are over 65 years of age, and 20% are older than 85 [5]

  • The average age of heart failure diagnosis is 77 years of age [7]

  • 57% of heart failure patients are women [5]

  • 30% of heart failure patients are non-white [8]

A study by Heiat, et al.  [9] reviewed 59 randomized controlled trials (RCT’s), consisting of 45,627 heart failure patients:

  • 80% of the trials studied drug efficacy

  • 5% studied health service interventions

  • 5% evaluated lifestyle-related interventions

  • 2% studied different procedures

Many trials explicitly excluded women, and the elderly

  • 29% of trials excluded elderly patients (this accounted for 44% of the overall patient population)

  • 7% of trials excluded women outright, with another 13% excluding those with child-bearing potential

 

Heart Failure Research (II)

Most HF trials did not include patients with preserved systolic ejection fraction, although this is a common condition in HF. This makes a bad situation worse, because studies consistently show that the majority of patients with this condition are older and female.

What all of this means is that the participants in heart failure clinical trials do not at all match those of the general patient population. Participants in RCT’s are most often younger, white males. The review by Heiat, et al. found that only 2 of the 59 trials accurately represented the general heart failure population with respect to sex and age. Also, only 2 studies explicitly targeted patients over the age of 65. No trials explicitly targeted women, or non-white populations. These trends were observed not only in privately funded trials, but also in trials funded by the government.

Unfortunately, this trend of bias in clinical research is not isolated to heart failure. The same trends are seen in mycardial infarction [10] and cancer treatment studies [11][12].

1.

Can you think of any reasons as to why women are so under-represented in heart failure research?

2.

Can you think of any reasons as to why elderly patients are so under-represented in heart failure research?

References for this Activity
1. Galvao M, Kalman J, Demarco T, Fonarow GC, Galvin C, Ghali JK, Moskowitz RM, on behalf of the adhere scientific advisory committee, investigators, coordinators and study group. Gender differences in in-hospital management and outocmes in patients with decompensated heart failure: analysis from the acute decompensated heart failure natoinal registry (ADHERE). Journal of Cardiac Failure. 2006;12(2):100-108.
2. Klapholz M. Maurer M, Lowe AM, Messineo F, Meisner JS, MItchell J, et al. Hospitalization for heart failure in the presence of a normal left ventricular ejection fraction: results of the New York Heart Failure Registry. J Am Coll Cardiol 2004;43:1432-8.
3. Adams KF, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observation from the first 100,00 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005;149:209-16.

 

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5. Popovic JR. Kovac LJ. National hospital discharge survey: annual summary. Vital Health Stat 13. 1998 2000;148:1-194

7. Senni M, Tribouilloy CM, Rodeheffer RJ, et al. Congestive heart failure in the community: a study of all incident cases in Olmsted County, Minnesota, in 1991. Circulation. 1998;98:2282-2289.

8. Trends in the health of older Americans: United States, 1994: Analytic and epidemiologic studies No. #. Vital Health Stat 3. 1995;30:1-328.

9. Heiat A, Gross CP, Krumholz HM. Representation of the Elderly, Women, and Minorities in Heart Failure CLinical Trials. Arch Intern Med 2002;162.

10. Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clincial trials in acute myocardial infarction. JAMA. 1992;268:1417-1422.

11. Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061-2067

12. Trimble EL, Carter CL, Cain D, Freidlin B, Ungerleider RS, Freidman MA. Representation of older patients in cancer treatment trials. Cancer. 1994;74:2208-2214.

All references for this section